TUSTIN, CA--(Marketwire - June 08, 2010) - Integrium LLC, a contract research organization (CRO) specializing in cardiovascular and metabolic disease clinical research, today announced its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology drug development expert, will lead Integrium's dedicated Dermatology Clinical Research Group.
Patient demand for medical and aesthetic dermatologic health care is on the rise, thanks in large part to aging baby boomers and an increasing number of available, cost-effective solutions. According to IMS Health, global therapeutic dermatology is an $18 billion market and growing -- and identifying key trends and addressing needs unique to dermatologic drug therapy development is critical for pharmaceutical companies to keep up with demand.
Integrium has differentiated itself by demonstrating a deep understanding of the complexities and nuances of clinical research in the dermatology area, and by delivering successful clinical study solutions to biopharmaceutical companies. The company's new Dermatology Clinical Research Group will help its clients design scientifically rigorous, yet feasible studies, leverage its relationships with reliable, high-quality investigators to help identify and recruit study patients, and effectively manage their studies from start to finish.
"We founded Integrium believing that a world-class team with experience levels far above industry norms would set us apart," said David Smith, M.D., Founding Partner and Chief Medical Officer, Integrium. "Dr. Spellman's appointment is very much in keeping with this approach. Our clients will benefit tremendously from her dermatology expertise and many years of drug development experience."
"Selecting the right CRO partner is critical to our success," said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on developing branded prescription products for the dermatology and women's health therapeutic areas. "We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies. They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial."
"I'm pleased to be leading Integrium's new dermatology clinical research group," said Dr. Spellman. "Integrium has earned a strong reputation for its expertise in cardiovascular and metabolic disease clinical trials -- and we look forward to carrying that same level of excellence to ensure our clients focused on dermatology studies are getting the support they need to bring better, safer therapies to market."
Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has been instrumental in achieving US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines, and has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.
Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications. Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is a member of the Board of Directors of the Women's Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.
Integrium will be exhibiting at DIA booth #228. Members of the media interested in speaking with Integrium should contact Juli Greenwood at 781-672-3137 or firstname.lastname@example.org.
About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients. Combining the Integrium Clinical Excellence (ICE) study start-up and management methodology, and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. For more information please visit www.integrium.com.